Transcatheter aortic-valve implantation (TAVI) has emerged as a therapeutic option to improve symptoms and extend life in high-risk patients with severe symptomatic Aortic Stenosis.
Various approaches have been described for accessing the aortic valve during the TAVI procedure. One TAVI approach is a transfemoral (TF) route in which catheters are guided through the aorta and retrograde across the diseased valve.
A second approach, the direct transaortic (TAo) route, mimics the TF route but avoids passing instruments along the curvature of manipulating the aortic arch, reducing the risk of embolization. While TAo-TAVI is currently performed through an upper ministernotomy or a right minithoracotomy, the aortic anatomy is such that the ascending aorta could be accessed percutaneously from just above the suprasternal notch. The ascending aorta would be pierced and cannulated. In some embodiments, cannulation might occur at the level of the second intercostal cartilage, where it lies anteromedial to the superior vena cava, although other sites might also be used.
The transition from surgical or vascular access to a direct percutaneous approach has the potential to reduce the requirement for general anesthesia, shorten procedure time, reduce the risk of wound infections, mitigate patient discomfort, reduce post-op patient immobilization, and shorten length of hospitalization. To realize the potential of percutaneous transaortic (pTAo) TAVI, however, new tools are needed for access, embolic protection, and closure.